The Drug Controller General of India on August 20 approved Zydus Cadila’s ZyCoV-D vaccine against COVID-19 for Emergency Use Authorization (EUA) for adults, children above 12 years. It is a three-dose vaccine that plays a crucial role in safeguarding from the disease, said the department of Biotechnology (DBT).
Being developed in association with the DBT, ZyCoV-D is the world’s first plasmid DNA vaccine against coronavirus. The jab would be inoculated using a needle-free applicator, unlike traditional syringes.
The Ministry of Science and Technology said, “The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring.”
The Ahmedabad-based pharmaceutical firm, Cadila Healthcare Ltd, applied for EUA on July 1. Its efficacy rate stands at 66.6% for symptomatic RT-PCR positive cases after the interim analysis from Phase-III Clinical Trials in more than 28,000 volunteers nationwide.
“The vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive phase I/II clinical trials carried out earlier. Both the phase I/II and phase-III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB),” the ministry further said.
In a step to fight against COVID-19, it becomes the sixth vaccine approved for use in the country, following Covishield, Sputnik, Johnson & Johnson, US-made Moderna, and locally produced Bharat Biotech’s Covaxin.
“It is a matter of great pride that today we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha. The Indian Vaccine Mission COVID Suraksha was launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is aimed at the development of safe and efficacious Covid-19 vaccines for public health,” news agency ANI quoted Dr Renu Swarup, Secretary, DBT and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC) as saying.
According to the pharmaceutical company, it held the mega clinical trial for the vaccine in India in more than 50 centres. Managing director, Cadila Healthcare, Sharvil Patel, stated that the vaccine would help adults and adolescents between 12 and 18 years.
DBT Secretary Swarup added, “We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our Indigenous Vaccine Development Mission and positions India on the Global Map for Novel Vaccine Development.”